Access to article: http://www.ncbi.nlm.nih.gov/pubmed/16390629

Iron deficiency anemia (IDA) is a significant public health problem among Canadian Aboriginal children. The objectives of this study were to determine the acceptability and safety of microencapsulated-iron sprinkles, a new powdered form of iron packaged in a single-serving sachet for prevention of IDA. A total of 102 non-anemic children aged 4 to 18 months from three communities were randomized to receive sprinkles containing 30 mg Fe/day (NR = 49) or placebo (NR = 53) for six months. To assess acceptability, adherence and side effects were monitored bi-weekly. To assess safety, serum ferritin (SF) concentration and anthropometry were measured at baseline and end. Mean adherence was 59.6 +/- 27.7 percent. There were no differences in adherence, SF, anthropometric status or side effects between groups. Although there were no differences in hemoglobin (Hb) concentration and anemia prevalence from baseline to end and between groups, the Hb curve shifted to the right (increased) for the sprinkles group and to the left (decreased) for the placebo group. Sprinkles may provide a safe and acceptable option to the current standard of care (i.e. ferrous sulphate drops) for the provision of iron in Canadian Aboriginal populations.

 

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Acceptability of Lipid-based Nutrient Supplements (LNS) for Women and Infants

Project Description:
In developing countries of Asia and Africa prevalence of anemia ranges from 45 to 76% and weaning infants, adolescent girls and women of reproductive age (WRA) are at particular risk. The etiology of anemia in Vietnam is multi-factorial thereby, necessitating interventions to address multiple causes of anemia to achieve the desired results. An operational research study was carried out in Vietnam and Benin as part of a collaboration with CARE and PATH Canada.
In Vietnam, important risk factors for anemia include the level of hookworm infection, living in remote or rural areas and consuming meat once or less per month. For women, having three or more children is also a risk factor. In addition, children less than two years are at higher risk of anemia.

Project Objectives:
To evaluate the efficacy of iron pots versus Sprinkles for infants and versus iron tablets for adolescents and women.
Key Findings:
The cure rate of anemia in infants was 96% and the prevalence of low iron stores fell from 44% to 23% after six months of supplementation with Sprinkles

Project Name:
Sprinkles use to improve iron status of infants aged 6-12 months
Project Category:
Clinical Research, Formative Research, Operational Research
Status of Project:
TBD
Implementing Organization:
University of the Philippines at Los Banos
Donor/Funding Agency:
Canadian Institutes of Health Research (planning grant)
Project Coverage:
TBD
Organizations Involved:
Organization: University of the Philippines at Los Banos
Type of Organization: University

Organization: Food and Nutrition Research Institute
Type of Organization: Government organization

WFP and the UBC Micronutrient Project are conducting a research project on MNP in Uganda

More info here: http://micronutrient.landfood.ubc.ca/projects/cameroon/

The Government of Cameroon has implemented several strategies to combat undernutrition and micronutrient deficiencies, however, none of the current strategies have specifically targeted iron deficiency anemia in children aged 6-23 months. Micronutrient fortification of industrially manufactured staple foods is regarded as the most cost effective approach to improving the population’s vitamin and mineral status, but this strategy is not considered adequate for the high needs of young children. Access to fortified complementary food for young children in Cameroon is out of reach for most families. Therefore this project has been developed in collaboration with the government and key stakeholders in order to target vulnerable children during the key first ‘1000 Days’ of life when their cognitive and physical development may be permanently impacted.

Objectives

To assess the feasibility and acceptability of MNP for home fortification in rural communities in Cameroon;
To develop and pilot a culturally appropriate protocol for MNP to be integrated with current IYCF programs; and
To develop a MNP communication strategy for caregivers, health professionals, and decision-makers.

http://clinicaltrials.gov/ct2/show/NCT00970840?term=00970840&rank=1


NCT00970840

This study is a taste test to confirm the acceptability of lipid-based nutrient supplements (LNS), which are semi-solid pastes comprising groundnut paste, milk, sugar, vegetable oil and micronutrients, for home fortification of foods consumed by infants and by pregnant and lactating women. Two types of supplements will be evaluated, one for infants (LNS20gM) and one for pregnant and lactating women (LNS P&L). The LNS-20gM is similar to the Nutributter we used previously in Ghana and provides generally the Recommended Nutrient Intakes (RNI) for 18 vitamins and minerals for infants from 6 to 18 mo of age. The LNS-P&L is modeled on the UNICEF/WHO/UNU international multiple micronutrient preparation (UNIMMAP) for pregnant and lactating women and similar products used in Guinea Bissau. Each supplement (20 g/day) will provide 118 kcal/day.

Procedures:The study will be carried out in two phases. The first test trial will be conducted within the premises of the Maternal and Child Health Clinics, where study participants will be recruited.

Potential study participants or their mothers (in the case of infants) will be asked verbally using a screening questionnaire at the time of recruitment if they are known to be intolerant to peanut or milk products, in which case they will be excluded. Because infants must have been receiving complementary foods at least 30 days prior to taking part in the study, this will not be too difficult to find out. For subjects unaware of whether they are intolerant to peanut or milk products, they will be asked not to go home immediately after finishing the experiment, but to continue to remain in (or around) the testing room for at least one hour whilst the study staff keep watch. Should there be any skin, respiratory or gastrointestinal symptoms in any subject during that time, they will be immediately referred to the hospital. When leaving the testing room for the home, those subjects (or their mothers) will be given the project's mobile phone number to call in case there are any symptoms during the next few hours.

Potential subjects or their mothers (in the case of infants) will be asked if they feel ill using the screening questionnaire. Subjects who report any feeling of illness will be excluded. The Maternal and Child Health clinics (MCH) where subjects will be recruited provide mainly routine services for women (such as ante-natal services for pregnant women) and children (such as weight monitoring and promotion and vaccination). We expect that nearly all women and infants attending these clinics will be apparently in good health and not ill.

Phase 1 - Test-feeding:

Study participants will be women (n = 20) = 18 y of age who are either pregnant (n = 10) or lactating (n = 10) and infants (n = 20 accompanied by their mothers) 6 - 12 mo of age randomly-selected from Maternal and Child Health clinics in Manya and Yiko Krobo districts of the Eastern Region of Ghana. All subjects must be apparently healthy and must not have eaten any food (including breast milk) during the previous one hour.

Test-feeding of LNS P&L: After consent, pregnant (n=10) and lactating women (n=10) will be asked to come to the clinic the next day for an orientation session during which background data will be collected and the experimental procedures will be practiced including tasting of the food and completion of the tasting questionnaire. The second day will be Test Day 1, during which the actual tasting will be recorded. Women will be asked to consume 45 g of koko mixed with LNS P&L (prepared from mixing 150 g LNS-P&L with 600 g fresh koko with moisture content of about 90%). Time taken to consume the entire amount, or proportion of the amount consumed within 15 minutes, will be measured. Women will be asked to rate the mixture's appearance, aroma, flavor, consistency and overall degree of liking using a hedonic scale. On the third day (Test Day 2) of the trial, the above procedures will be repeated using koko mixed with Nutributter instead. Koko for the test feeding will be provided by the project. Project staff will purchase fermented dough (the main ingredient) from the local market to prepare the koko under good hygienic conditions in our project house. After preparation, the koko will be kept hot in a thermos flask prior to being served to study participants at the MCH clinic. Between the time the koko is prepared and the time the test feeding is completed, which will take 2-3 hours, the koko can be kept at a temperature of 70 - 90 °C inside the thermos flask to prevent bacterial contamination. The Nutributter and the LNS supplements will be commercially produced by Nutriset SAS (Malaunay, France) and provided to the Project for testing.
Test-feeding of LNS20gM:
After consent, the mother (or care-taker) of each participating infant will be asked to come to the clinic with the child the next day for an orientation session during which background data will be collected and the experimental procedures will be practiced including tasting of the food and completion of the tasting questionnaire. The second day will be Test Day 1, during which the actual tasting will be recorded. Mothers or caretakers will be given 50 g of koko mixed with LNS 20gM (prepared from mixing 150 g LNS-20gM with 600 g fresh koko with moisture content of about 90%). They will be asked to consume one teaspoon of the mixture (~ 5 g), and then feed the rest (~ 45 g) to their infants after it is re-weighed. During this time, the child should be awake and alert, and either calm or fussy - but not drowsy or crying. Time taken by the child to consume the remaining portion, or proportion consumed by the child within 15 minutes, will be measured. The mother or caretaker will then rate the mixture's appearance, aroma, flavor and consistency based on her own opinion, and her perception of the infant's degree of liking. Mothers will be asked to report to us if the child vomits in the next hour, or develops any new symptoms such as rash or wheezing. On the third day (Test Day 2) of the trial, the above procedures will be repeated using koko mixed with Nutributter instead.

Phase 2 - Assessment under real-life conditions:

Pregnant and lactating women who participated in the Phase 1 trial will be given a two-week supply of LNS P&L, which they will add to their prepared food daily during the two-week period. Mothers of children who participated in the Phase 1 trial will receive LNS20gM, which they will add to their infants' prepared food for 2 weeks. The dose for LNS P&L or LNS20gM is 20 g/day. To ensure that subjects consume the entire daily dose, women will be instructed, as done previously in our study in Ghana, to mix their own or their infant's daily dose with 2-3 tablespoons of the food, to be consumed before consuming the rest of the food.

Dosage and directions for use will be as follows: 20 g (~4 teaspoons) per day divided into 2 portions and consumed at two different times of the day (2 x 2 teaspoons). Mix the portion of the supplement to be consumed with 2-3 tablespoons of the already prepared food, and eat the mixture before eating the rest of the food. Do not cook food with the supplement. Store supplement at room temperature. There is no need for refrigeration.

A structured questionnaire will be used to gather background information on socioeconomic status, and maternal and infant feeding behavior. The amount of LNS consumed by subjects will be monitored weekly, and the reactions to the products will be obtained at the end.

http://clinicaltrials.gov/ct2/show/NCT00944281?term=NCT00944281&rank=1

Descriptive Information
Brief Title ICMJE Optimal Amount of Zinc to Include in a Lipid-based Nutrient Supplement (LNS)
Official Title ICMJE A Randomized, Double-blind, Controlled Trial in Rural Burkina Faso to Determine the Optimal Amount of Zinc to Include in a Lipid-based Nutrient Supplement (LNS). Part of the iLiNS Study
Brief Summary
To assess zinc-related biochemical and functional responses among young Burkinabe children with a presumed high risk of zinc deficiency who receive micronutrient products containing different amounts of zinc, provided with or between meals.

Detailed Description
Young healthy children will be identified by periodic consensus in the study area. 3200 infants meeting a set of eligibility criteria will be randomly assigned to receive lipid-based nutrient supplements (LNS) with different amounts of zinc and a placebo or zinc supplement from 9 to 18 months of age. The families will receive the respective supplement at weekly intervals and the participants undergo a morbidity evaluation weekly, anthropometric evaluation at 9, 12, 15 and 18 months and laboratory analyses at enrollment and at 18 months of age. Growth outcomes will be analyzed during the two-year follow up at 24, 30, 36 and 42 months of age.

Study Type ICMJE Interventional
Study Phase Phase 4
Study Design ICMJE Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition ICMJE Malnutrition
Intervention ICMJE
Dietary Supplement: LNS-Zn5
Daily consumption of 20 g LNS containing 5 mg of zinc and daily placebo supplement
Other Name: Nutriset
Dietary Supplement: LNS-Zn10
Daily consumption of 20 g LNS containing 10 mg of zinc and daily placebo supplement
Other Name: Nutriset
Dietary Supplement: LNS-Zn0
20 g of LNS containing 0 mg of zinc and a daily placebo supplement
Other Name: Nutriset
Dietary Supplement: Suppl-Zn5
Daily 5 mg zinc supplement ant consumption of 20 g LNS containing 0 mg of zinc
Other Name: Nutriset
Study Arm (s)
Experimental: LNS-Zn5
Daily intake of 20 g LNS containing 5 mg of zinc and a daily placebo supplement
Intervention: Dietary Supplement: LNS-Zn5
Experimental: LNS-Zn10
Daily intake of 20 g LNS containing 10 mg of zinc and a daily placebo supplement
Intervention: Dietary Supplement: LNS-Zn10
Placebo Comparator: LNS-Zn0
Daily intake of 20 g LNS containing 0 mg of zinc and a daily placebo supplement
Intervention: Dietary Supplement: LNS-Zn0
Experimental: Suppl-Zn5
Daily intake of zinc supplement containing 5 mg of zinc and 20 g LNS containing 0 mg of zinc
Intervention: Dietary Supplement: Suppl-Zn5
No Intervention: Delayed intervention group
Standard care from age 8 to 18 months. Daily consumption of LNS from age 18 to 28 months.
Publications * Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ICMJE Active, not recruiting
Estimated Enrollment ICMJE 3200
Estimated Completion Date December 2014
Estimated Primary Completion Date December 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ICMJE
Inclusion Criteria:

9.0 to 9.9 mo of age
Exclusion Criteria:

severe anemia
severely malnourished
presence of bipedal oedema
severe illness
congenital abnormalities
chronic medical condition
known HIV infection of mother or infant
history of peanut allergy
history of anaphylaxis or serious allergic reaction to any substance
Gender Both
Ages 9 Months to 9 Months
Accepts Healthy Volunteers Yes
Contacts ICMJE Contact information is only displayed when the study is recruiting subjects
Location Countries ICMJE Burkina Faso

Administrative Information
NCT Number ICMJE NCT00944281
Other Study ID Numbers ICMJE 236850, iLiNS-Zinc
Has Data Monitoring Committee No
Responsible Party University of California, Davis
Study Sponsor ICMJE University of California, Davis
Collaborators ICMJE Université Polytechnique de Bobo-Dioulasso
Investigators ICMJE
Study Director: Kathryn Dewey, PhD University of California, Davis
Principal Investigator: Kenneth H Brown, MD University of California, Davis
Information Provided By University of California, Davis
Verification Date August 2014

The ‘Home Fortification Programme with MNP for Young Children in Zambia’ has been designed as a multiphase project with the first phase consisted of two components, a feasibility study and a 30-day trial of MNP. The feasibility study included key informant interviews and focus group discussions, which assessed current feeding practices, perception of MNP, potential barriers to MNP introduction, knowledge of anaemia, and tested local package designs. This component was completed in May 2012. The second component, a 30-day trial of MNP, was completed in July 2012, and assessed the acceptability and utilisation of MNP among 60 households using two different delivery strategies. The findings of the feasibility study and the 30-day trial compiled in two separate reports have been integrated into the design of the pilot phase, which will ultimately inform how best to operationalise and scale up the MNP intervention in Zambia. Furthermore, the earlier work has been used to finalise the training manuals, training guidelines, instructions of use, FAQ, and communication & advocacy materials for MNP, for the pilot phase as well as the Zambian package design.

Starting in April 2013, the second phase will be a 12-month pilot implementation of MNP for children 6-23 months of age in selected catchment areas of two districts of Northern Province. It is estimated to reach approximately 5’000 children 6-23 months. An impact evaluation (effectiveness study) has been embedded within the pilot programme to assess the effect of MNP plus IYCF intervention package in relation to the programme’s goals and outcomes of a sub-sample in the targeted areas under programmatic conditions. Impact evaluation will be a periodic activity, and will consist of collecting and analysing data at baseline, mid-term (6-months), and end-line (12 months) of the project. Data will be collected on a range of variables to allow for interpretation and understanding of programme impact pathways. Not all of the desired programme goals and outcomes may show an observable change across 12 months and therefore proxy indicators will be also used.

There will be three distinct groups invited to participate in the effectiveness component of the pilot in order to compare findings across the two geographic districts of Mbala and Kaputa, and additionally, within Kaputa, between households receiving cash transfers and those not receiving cash transfers.

The methods have been developed in accordance with the overall pilot programme goals and objectives, taking into consideration the limitations of implementing a rigorous scientific design in resource poor settings where access, transportation and communication, are limited.

Read more here: http://micronutrient.landfood.ubc.ca/projects/zambia/

read more here: http://micronutrient.landfood.ubc.ca/projects/mozambique/

In view of the unacceptably high prevalence of anaemia and the lack of a national program to control iron deficiency in young children, the Ministry of Health with financial and technical support from Irish Aid and GAIN plans to introduce MNP for controlling and preventing iron deficiency anaemia in children aged 6-23 months. In addition, it will create appropriate linkages with the IYCF program, which aims at improving overall physical and mental development of young children.

The MNP introduction will be done through three steps: (1) conduct formative research on MNP acceptability & utilisation with a 30-day trial, (2) pilot the MNP intervention, and (3) scale up of the MNP intervention.

The study will be conducted in one rural and one urban community. In the 30-day trial, mothers with children aged 6-23 months will receive MNP, in order to assess the MNP acceptability and utilization. Both groups of 30 mother-child pairs, one in a rural and one in an urban setting, will be given 30 sachets for 30 days. The mothers will be interviewed at three points during the 30-day period, at baseline, after 10 days and after 30 days. Mothers will undergo IYCF and MNP training, delivered by a healthcare provider. These healthcare providers will previously be trained by the research team on IYCF principles, with a focus on complementary feeding, and the incorporation of MNP, using information and fact sheets. The training will also include the demonstration of MNP use with mashed or soft, semi-solid foods such as porridge, and the provision of locally branded MNP sachets.

Research Objectives

To develop culturally acceptable information, communication and training materials, on MNP as part of complementary feeding.
To assess the acceptability and utilization of MNP across a 30-day period of their use in the household for 6-23 month old children.
To evaluate communication and training materials on MNP by assessing information retained by caregivers 10 and 30 days after training.
To test local branding and packaging for MNP.
To inform the design of the home fortification pilot based on findings from the formative work.

For more information: http://www.amway.com/about-amway/citizenship/amway-one-by-one/nutrilite-little-bits


Amway partnered with Un Kilo de Ayuda and the Instituto Nacional de Nutrición Salvador Zubirán (Salvador Zubirán National Institute of Nutrition in Mexico) to test the efficacy of the NUTRILITE® Little Bits program in a pilot study in Mexico involving approximately 125 children ages 1 to 5 years old. The results from this clinical study exceeded our expectations. Prevalence of iron deficiency anemia was reduced by nearly 90% after 6 months of intervention. Prevalence of stunting was reduced by 18%. Prevalence of low body weight was reduced by more than 6%. And children showed to be more active, talkative, and playful in just 6 months. This clinical study is currently going through the stages of publication. The abstract* was presented at the Second World Congress of Public Health Nutrition and the First Latin American Congress of Community Nutrition in September 2010 in Porto, Portugal.

In July 2012, Amway staff visited Lusaka, Zambia to monitor a program that uses Nutrilite Little Bits to support the nutritional health of children. We partner with the Christian Alliance for Children in Zambia, an agency on the ground that provides food, medicine and education to support mothers and children.

Chronic malnutrition affects roughly 45 percent of children in Zambia, and the Nutrilite Little Bits micronutrient intervention, added to any native food, contains 15 vitamins and minerals that provide nourishment and fortification to a child. Currently, 229 children in six communities in Zambia benefit from Nutrilite Little Bits.

The monitoring trip highlighted dramatic improvement in health of the children in the program, both in technical results and real-life stories.

Amway team members who were in Zambia last year were deeply moved by the improvements in the children – with greater health, higher activity levels … and more smiles. A little bit is going a long way!

More info here: http://blogs.amway.com/onebyone/2012/09/28/an-update-from-zambia/

http://clinicaltrials.gov/ct2/show/study/NCT00944814?term=NCT00944814&rank=1

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944814

Purpose
The purpose of the study is to assess the acceptability of the two lipid-based nutrient supplement (LNS) formulations containing no zinc and a high amount of zinc (10 mg zinc / 20 g dose of LNS). The hypothesis is that both products will be equally accepted by children and mothers.


Condition Intervention Phase
Malnutrition
Dietary Supplement: LNS with zinc
Dietary Supplement: LNS without zinc
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Assessment of the Acceptability of Zinc-fortified Lipid Based Nutrient (LNS) Prepared for Young Burkinabe Children

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Malnutrition
U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
Amount of each type of LNS formulation consumed by young children [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Preference and detection of differences between LNS formulations among mothers [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Acceptability of feeding LNS to young children at home [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: July 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LNS with zinc
LNS containing 10 mg zinc per 20 g dose of LNS
Dietary Supplement: LNS with zinc
Lipid-based nutrient supplement (LNS) containing 10 mg zinc/20 g LNS dose
Other Name: Nutriset lipid-based nutrient supplement with zinc
Placebo Comparator: LNS without zinc
LNS containing no zinc
Dietary Supplement: LNS without zinc
LNS containing no zinc
Other Name: Nutriset lipid-based nutrient supplement without zinc

Detailed Description:
We plan to conduct a series of acceptability studies to: 1) assess the amounts of zinc-free and high-zinc LNS consumed by children during direct observation, 2) compare their mothers' sensory assessments of the respective products, and 3) review maternal reports of their child feeding experiences during more prolonged home feeding trials.

Eligibility

Ages Eligible for Study: 9 Months to 15 Months
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:

Currently breast-feeding and consuming complementary foods for at least 30 d
Exclusion Criteria:

Height-for-age and weight-for height Z-scores <-3 with respect to WHO growth standards
Edema
Diarrhea and other diseases that could interfere with food intake
Severe systemic illness
History of peanut allergy
History of anaphylaxis/serious allergic reaction
Infants meeting these criteria and their mother's will be invited to participate

Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944814

Locations
Burkina Faso
Institut de Recherche en Sciences de la Santé
Bobo-Dioulasso, Burkina Faso
Sponsors and Collaborators
University of California, Davis
Université Polytechnique de Bobo-Dioulasso
Helen Keller International
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Kenneth H. Brown, MD University of California, Davis
More Information

No publications provided

Responsible Party: Prof. Kenneth H. Brown, University of California Davis
ClinicalTrials.gov Identifier: NCT00944814 History of Changes
Other Study ID Numbers: 200917273, iLiNS-ACCEPT-Zinc
Study First Received: July 21, 2009
Last Updated: February 18, 2010
Health Authority: Burkina Faso: Ministry of Health

Keywords provided by University of California, Davis:
Lipid-based nutrient supplement
Prevention of malnutrition
Prevention of micronutrient deficiencies
Zinc

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2014

http://clinicaltrials.gov/ct2/show/NCT00885144?term=%28Malawi+OR+Burkina%29+AND+LNS&rank=1


Descriptive Information
Brief Title ICMJE Trial on the Acceptability of Modified Lipid Based Nutrient Supplements Among Malawian Infants
Official Title ICMJE Differential Acceptability of New Lipid Based Nutrient Supplement (LNS) Formulations for Prevention of Moderate Malnutrition
Brief Summary
The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. The investigators' study group has developed modified versions of such supplements that theoretically will supplement infants diets better and with lower cost. As a preparation for larger efficacy trials, the investigators now aim to test the acceptability of these supplements among Malawian infants and their guardians. The trial hypothesis is that the infants will consume on average at least 50% of an offered dose that consists of LNS mixed with maize porridge.

Detailed Description
In the first phase, 18 infants meeting set criteria are randomised into receiving three test meals with novel LNS preparations over a three-day period. The meals will consists of the following, each given on one day and in a random order: 1) 7.5 g of LNS-10gM mixed in 30 g maize-soy porridge, 2) 15 g of LNS-20gM mixed in 30 g maize-soy porridge, 3) 15 g of LNS-20gNoM mixed in 30 g maize-soy porridge. As a run in procedure, each participant will undergo a test feeding session with one of the the test foods on the day before the actual test-feeding period. As a positive control, each participant will undergo test feeding session with standard Nutributter (NB) on the day after the actual test-feeding period.

In the second phase a set of 48 infants are randomised into 3 groups receiving the following food supplements for a period of 2 weeks: 1) 10 g/day of milk-containing, very concentrated LNS (LNS-10gM), 2) 20 g/day of milk-containing, concentrated LNS (LNS-20gM), 3) 20 g/day of milk-free, concentrated LNS (LNS-20 g NoM)

Outcomes measures in the first phase will be assessed through safety reports and quantities of test food consumed by the child and a hedonic scale of acceptability by the mothers of the children. The second phase will be assessed with qualitative outcomes, from data obtained from focus group discussions with the guardians of the infants consuming the test foods.

Study Type ICMJE Interventional
Study Phase Phase 1
Study Design ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Condition ICMJE Malnutrition
Intervention ICMJE
Dietary Supplement: Nutributter
Test dose of "standard" supplementary lipid based nutrient supplement (LNS). 15 grams of Nutributter will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.
Dietary Supplement: LNS-20gM
Test dose of modified LNS-20gM supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-20gM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.
Dietary Supplement: LNS-20gNoM
Test dose of modified LNS-20gNoM (milk free) supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-20gNoM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.
Dietary Supplement: LNS-10gM
Test dose of modified LNS-10gM supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-10gM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.
Study Arm (s) Not Provided
Publications * Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ICMJE Completed
Enrollment ICMJE 19
Completion Date June 2009
Primary Completion Date June 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ICMJE
Inclusion Criteria:

Signed informed consent from at least one guardian
Age 7.50 months to 11.49 months
Currently breastfeeding
Consuming complementary feeds at least 30 days prior to enrollment
Availability during the period of the study
Exclusion Criteria:

Weight for length Z score (WFH) = -2.0 using WHO growth reference standards or the -presence of oedema
Severe systemic illness warranting hospital referral
History of allergy towards peanut
History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
Congenital malformation such as cleft palate which may interfere with food intake
Concurrent participation in any other clinical trial
Gender Both
Ages 8 Months to 12 Months
Accepts Healthy Volunteers Yes
Contacts ICMJE Contact information is only displayed when the study is recruiting subjects
Location Countries ICMJE Malawi

Administrative Information
NCT Number ICMJE NCT00885144
Other Study ID Numbers ICMJE iLiNS-ACCEPT-M
Has Data Monitoring Committee No
Responsible Party Per Ashorn / Professor of International Health, University of Tampere
Study Sponsor ICMJE University of Tampere
Collaborators ICMJE
University of Malawi College of Medicine
University of California, Davis
Bill and Melinda Gates Foundation
Investigators ICMJE
Principal Investigator: Per Ashorn, MD, PhD University of Tampere
Principal Investigator: Kenneth Maleta, MBBS, PhD University of Malawi College of Medicine
Information Provided By University of Tampere
Verification Date June 2009

http://clinicaltrials.gov/ct2/show/NCT00945698?term=NCT00945698&rank=1

This study is ongoing, but not recruiting participants.
Sponsor:
University of Tampere
Collaborators:
University of Malawi College of Medicine
University of California, Davis
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Per Ashorn, University of Tampere
ClinicalTrials.gov Identifier:
NCT00945698
First received: July 21, 2009
Last updated: May 20, 2014
Last verified: May 2014
History of Changes

Descriptive Information
Brief Title ICMJE Prevention of Linear Growth Failure in Infants and Young Children With Lipid-based Nutrient Supplements (iLiNS-DOSE)
Official Title ICMJE A Two-centre, Randomised, Single-blind, Parallel Group Controlled Trial, Testing the Growth Promoting Effect of Long-term Complementary Feeding of Infants With Different Doses and Formulations of Lipid-based Nutrient Supplements (LNS)
Brief Summary
The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to infants and their guardians in Malawi and Ghana. In the present trial, the investigator aim to identify the lowest growth-promoting daily dose of modified LNS. Additionally, the investigators will test a hypothesis that LNS that does not contain milk promotes growth as well as milk-containing LNS when given for 12 months at a 10-40 g daily dose to 6-18 month old infants in rural Malawi.

Detailed Description
Six-month old healthy infants are identified through community surveys in the study area. 1920 infants meeting set criteria are randomised into receiving the following intervention between 6 and 18 months of age: 1) standard treatment from 6-18 months (i.e.no supplements, with delayed intervention between 18-30 months of age (ST-DI), 2) 10 g / day milk-containing LNS (LNS-10gM), 3) 20 g / day milk-containing LNS (LNS-20gM), 4) 20 g / day milk-free LNS (LNS-20gNoM), 5) 40 g / day milk-containing LNS, (LNS-40gM) 6) 40 g / day milk-free LNS (LNS-40gNoM). The families receive the food supplements at 2-weekly intervals and the participants undergo a morbidity evaluation weekly, a limited development assessment at 4-weekly intervals and anthropometric evaluation at 26-week intervals and laboratory analyses at enrollment and at 18 months. Growth outcome analyses are done at 18 and at 42 months of age.

Study Type ICMJE Interventional
Study Phase Phase 3
Study Design ICMJE Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Condition ICMJE Malnutrition
Intervention ICMJE
Dietary Supplement: Lipid-based nutrient supplement, 10gM
140 g of milk-containing LNS (LNS-10gM) 2-weekly (10 g / day) between 6 and 18 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Dietary Supplement: Lipid-based nutrient supplement, 20gM
280 g of milk-containing LNS (LNS-20gM) 2-weekly (20 g / day) between 6 and 18 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Dietary Supplement: Lipid-based Nutrient Supplement, 20gNoM
280 g of milk-free LNS (LNS-20gNoM) 2-weekly (20 g / day) between 6 and 18 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Dietary Supplement: Lipid-based nutrient supplement, 40gM
560 g of milk-containing LNS (LNS-40gM) 2-weekly (40 g / day) between 6 and 18 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Dietary Supplement: Lipid-based Nutrient Supplement, 40gNoM
560 g of milk-free LNS (LNS-40gNoM) 2-weekly (40 g / day) between 6 and 18 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Dietary Supplement: Maize-soy flour
No food supplement during the primary trial period (6 to 18 months of age)
1 kg fortified maize / soy flour (Likuni phala, LP) 2-weekly (71 g / day) between 18 and 30 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Study Arm (s)
ST-DI (Delayed intervention)
1 kg fortified maize / soy flour (Likuni phala, LP) 2-weekly (71 g / day) between 18 and 30 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Intervention: Dietary Supplement: Maize-soy flour
Experimental: LNS-10gM
140 g of milk-containing LNS (LNS-10gM) 2-weekly (10 g / day) between 6 and 18 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Intervention: Dietary Supplement: Lipid-based nutrient supplement, 10gM
Experimental: LNS-20gM
280 g of milk-containing LNS (LNS-20gM) 2-weekly (20 g / day) between 6 and 18 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Intervention: Dietary Supplement: Lipid-based nutrient supplement, 20gM
Experimental: LNS-20gNoM
280 g of milk-free LNS (LNS-20gNoM) 2-weekly (20 g / day) between 6 and 18 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Intervention: Dietary Supplement: Lipid-based Nutrient Supplement, 20gNoM
Experimental: LNS-40gM
560 g of milk-containing LNS (LNS-40gM) 2-weekly (40 g / day) between 6 and 18 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Intervention: Dietary Supplement: Lipid-based nutrient supplement, 40gM
Experimental: LNS-40gNoM
560 g of milk-free LNS (LNS-40gNoM) 2-weekly (40 g / day) between 6 and 18 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Intervention: Dietary Supplement: Lipid-based Nutrient Supplement, 40gNoM
Publications *
Adu-Afarwuah S, Lartey A, Brown KH, Zlotkin S, Briend A, Dewey KG. Home fortification of complementary foods with micronutrient supplements is well accepted and has positive effects on infant iron status in Ghana. Am J Clin Nutr. 2008 Apr;87(4):929-38.
Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Complementary feeding with fortified spread and incidence of severe stunting in 6- to 18-month-old rural Malawians. Arch Pediatr Adolesc Med. 2008 Jul;162(7):619-26.
Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Postintervention growth of Malawian children who received 12-mo dietary complementation with a lipid-based nutrient supplement or maize-soy flour. Am J Clin Nutr. 2009 Jan;89(1):382-90. Epub 2008 Dec 3.
Kumwenda C, Dewey KG, Hemsworth J, Ashorn P, Maleta K, Haskell MJ. Lipid-based nutrient supplements do not decrease breast milk intake of Malawian infants. Am J Clin Nutr. 2014 Mar;99(3):617-23. doi: 10.3945/ajcn.113.076588. Epub 2013 Dec 24.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ICMJE Active, not recruiting
Estimated Enrollment ICMJE 1920
Estimated Completion Date August 2014
Primary Completion Date August 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ICMJE
Inclusion Criteria:

Signed informed consent from at least one guardian
Age 5.50 months to 6.49 months
Availability during the period of the study.
Permanent resident of Mangochi District Hospital or Namwera Health Centre catchment area
Exclusion Criteria:

Weight for length Z score (WLZ) < -2.0
Presence of oedema
Severe anaemia (Hb<50 g / l)
Severe illness warranting hospital referral
History of allergy towards peanut
History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
Concurrent participation in any other clinical trial
Gender Both
Ages 167 Days to 197 Days
Accepts Healthy Volunteers Yes
Contacts ICMJE Contact information is only displayed when the study is recruiting subjects
Location Countries ICMJE Malawi

Administrative Information
NCT Number ICMJE NCT00945698
Other Study ID Numbers ICMJE iLiNS-DOSE
Has Data Monitoring Committee Yes
Responsible Party Per Ashorn, University of Tampere
Study Sponsor ICMJE University of Tampere
Collaborators ICMJE
University of Malawi College of Medicine
University of California, Davis
Bill and Melinda Gates Foundation
Investigators ICMJE
Principal Investigator: Per Ashorn, MD, PhD University of Tampere Medical School
Principal Investigator: Kenneth Maleta, MBBS, PhD University of Malawi College of Medicine
Information Provided By University of Tampere
Verification Date May 2014

ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

http://clinicaltrials.gov/ct2/show/NCT01239693?term=NCT01239693&rank=1

This study is ongoing, but not recruiting participants.
Sponsor:
University of Tampere
Collaborators:
University of Malawi College of Medicine
University of California, Davis
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Per Ashorn, University of Tampere
ClinicalTrials.gov Identifier:
NCT01239693
First received: November 10, 2010
Last updated: February 2, 2014
Last verified: February 2014
History of Changes

Descriptive Information
Brief Title ICMJE Supplementing Maternal and Infant Diet With High-energy, Micronutrient Fortified Lipid-based Nutrient Supplements (LNS)
Official Title ICMJE A Research Plan for a Randomised, Single-blind, Parallel Group Controlled Trial in Rural Malawi, Testing the Health Effects of Supplementing Maternal Diet During Pregnancy and Lactation and Infant Diet From 6 to 18 Months of Age With High-energy, Micronutrient Fortified Lipid-based Nutrient Supplements (LNS)
Brief Summary
The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to pregnant women in Malawi and Ghana. In the present trial, the investigators aim to test the effect of LNS on pregnancy and child outcomes, when given during pregnant and lactating women and their infants from 6 to 18 months of age. In control groups, participants will receive either iron+folate tables during pregnancy only or multiple micronutrient tablets during pregnancy and first six months of lactations. The main hypothesis to be tested suggests that the mean length-for-age Z-score (LAZ) of 18-month-old infants who received LNS between 6 and 18 months of age and whose mothers were provided with LNS during pregnancy and the first 6 months of lactation is higher than the mean LAZ score of same age infants who received no dietary supplements and whose mothers received iron-folate supplementation during pregnancy only.

Detailed Description
Pregnant women will be identified from the antenatal clinics of 4 governmental and 2 other health centres. A total of 1400 women meeting set criteria will be randomised into receiving one of the following interventions: 1) Iron and folic acid supplementation to the mother during pregnancy only (IFA group), 2). Multiple micronutrient supplementation to the mother during pregnancy and six months thereafter (MMN group), 3) Lipid-based nutrient supplements to the mother during pregnancy and six months thereafter and to the child from 6 to 18 months of age (LNS group).

The mothers will receive LNS or the multiple micronutrients at 2-weekly intervals at their homes during pregnancy and weekly during first six months of lactation. Children in the LNS group will receive LNS weekly, starting at 6 months. Mothers will be medically examined and tested for defined laboratory parameters at enrolment, at 36 gestation weeks, at birth or soon thereafter, and at 6 months after delivery. Child size will be assessed at birth or soon thereafter and at 3, 6, 12, and 18 months of age. The mothers will undergo a morbidity evaluation fortnightly and the children weekly.

864 mother-infant pairs will undergo the complete intervention and follow-up, as described above. The remaining 536 participants will undergo a simplified intervention and follow-up, in which there are no interventions after birth and the child follow-up consists only of 4 3 health centre and one home visits; first at 1 week, then at six weeks (at home) and at 6 and 18 months of age.

A stubstudy on the the development of intestinal microbiome was added in August 2011. This entails the collection of stool samples from the mother at 1 month after delivery, breast milk samples from the mothers at 1, 3, and 6 months after delivery and stool and urine samples from the children repeated during the a8 months of intervention. The aim of this subproject is to study the development of the infants' intestinal microbiota, its predictors and its association to child growth and other health outcomes. At the same time point, the sample size was reduced from 2400 to 1400 particpants (due to constraints in funding).

A one year post-intervention follow-up for participants in the complete follow-up was added to the study protocoll in August 2013. The intervention will be stopped when the particpants are 18 months old. Thereafter, there will be an anthropometirc assessment and blood and urine draw at the study clinic at 24 and 30 months of age. Stool samples will be collected from the participants at the age of 21, 24, 27 and 30 months, to study the development of intestinal microbiome.

Study Type ICMJE Interventional
Study Phase Phase 3
Study Design ICMJE Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Condition ICMJE
Infant Malnutrition
Malnutrition in Pregnancy
Intervention ICMJE
Dietary Supplement: IFA
Women during pregnancy: 1 tablet of iron+ folate daily until delivery (60 mg iron + 400 ug folic acid) Women during lactation (from delivery to 6 months post-partum): 1 daily tablet of calcium (200 mg), akin to placebo Children from 6 to 18 months of age: None
Dietary Supplement: MMN
Women during pregnancy: 1 tablet of multiple micronutrients daily until delivery Women during lactation (from delivery to 6 months post-partum): 1 daily tablet of multiple micronutrients Children from 6 to 18 months of age: None
Dietary Supplement: LNS
Women during pregnancy: 1 sachet of LNS-P&L (20 g of LNS) daily until delivery Women during lactation (from delivery to 6 months post-partum): 1 daily sachet of LNS-P&L (20 g of LNS) Children from 6 to 18 months of age: 2 daily sachet of LNS-20gM (20 g of LNS)
Study Arm (s)
Active Comparator: IFA group
Women during pregnancy: 1 tablet of iron+ folate daily until delivery (60 mg iron + 400 ug folic acid) Women during lactation (from delivery to 6 months post-partum): 1 daily tablet of calcium (200 mg), akin to placebo Children from 6 to 18 months of age: None
Intervention: Dietary Supplement: IFA
Active Comparator: MMN group
Women during pregnancy: 1 tablet of multiple micronutrients daily until delivery Women during lactation (from delivery to 6 months post-partum): 1 daily tablet of multiple micronutrients' Children from 6 to 18 months of age: None
Intervention: Dietary Supplement: MMN
Experimental: LNS group
Women during pregnancy: 1 sachet of LNS-P&L (20 g of LNS) daily until delivery Women during lactation (from delivery to 6 months post-partum): 1 daily sachet of LNS-P&L (20 g of LNS) Children from 6 to 18 months of age: 2 daily sachet of LNS-20gM (20 g of LNS)
Intervention: Dietary Supplement: LNS
Publications * Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ICMJE Active, not recruiting
Enrollment ICMJE 1391
Estimated Completion Date December 2015
Estimated Primary Completion Date April 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ICMJE
Inclusion Criteria:

Ultrasound confirmed pregnancy of no more than 20 completed gestation weeks
Permanent resident of Mangochi District Hospital, Malindi Hospital or Lungwena Health Centre catchment areas
Availability during the period of the study
Signed informed consent
Exclusion Criteria:

Less than 15 years of age
Need for frequent medical attention due to a chronic health condition
Diagnosed asthma treated with regular medication
Severe illness warranting hospital referral
History of allergy towards peanuts
History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
Pregnancy complications evident at enrolment visit (moderate to severe oedema, blood Hb concentration < 5 g / dl, systolic blood pressure (BP) > 160 mmHg or diastolic BP > 100 mmHg)
Earlier participation in the iLiNS-DYAD-M trial
Concurrent participation in any other clinical trial
Gender Both
Ages 15 Years and older
Accepts Healthy Volunteers Yes
Contacts ICMJE Contact information is only displayed when the study is recruiting subjects
Location Countries ICMJE Malawi

Administrative Information
NCT Number ICMJE NCT01239693
Other Study ID Numbers ICMJE iLiNS-DYAD-M
Has Data Monitoring Committee Yes
Responsible Party Per Ashorn, University of Tampere
Study Sponsor ICMJE University of Tampere
Collaborators ICMJE
University of Malawi College of Medicine
University of California, Davis
Bill and Melinda Gates Foundation
Investigators ICMJE
Principal Investigator: Per Ashorn, MD, PhD University of Tampere Medical School
Information Provided By University of Tampere
Verification Date February 2014

ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

In recent decades, numerous strategies for the prevention and control of anemia and iron deficiency in childhood have been adopted by different countries, albeit without great success. Recently, the World Health Organization (WHO) suggested the use of sachets of micronutrients in powder for addition in child feeding, integrated with basic healthcare actions and adoption of a healthy diet.

Based on this recommendation, four Brazilian cities – Goiânia (GO), Olinda (PE), Porto Alegre (RS) and Rio Branco (AC) were involved in the Brazilian Study for Home Fortification of Complementary Feeding (ENFAC), which assessed the effectiveness of the micronutrient sachet, its adherence by mothers and acceptability among infants aged 6-8 months attended at basic health units, the target population of the study

From the iLiNS Project: http://www.ilins.org/ilins-project-research/protocols

Title of the Study: Effect of daily consumption of a micronutrient-fortified, energy-dense lipid-based nutrient supplement (LNS) on breast milk intake in Malawian infants
Investigators
Kathryn Dewey (PI), Marjorie Haskell (Co-PI), Kenneth Maleta (Co-PI), Per Ashorn (Co-Investigator), Chiza Kumwenda (Graduate student researcher), Jaimie Hemsworth (Graduate student researcher)
Background and design
This study is designed as a sub-study within a larger randomized controlled trial (called “iLiNS-DOSE”) that we are currently conducting in rural Malawi to evaluate the effect of daily consumption of a micronutrient-fortified, energy dense, lipid-based nutrient supplement (LNS) on growth and development in infants.
The World Health Organization recommends that infants receive breast milk exclusively until they reach 6 months of age. However, infants in rural Malawi typically receive maize porridge at 3-4 mo of age, and begin to experience growth faltering by about 4 mo of age. By 18 mo of age stunting and underweight are common and 30-50% of all Malawian children <5 y of age are stunted or underweight (UNICEF, 2006). Provision of LNS, in the form of a paste that can be added directly to complementary foods prepared in the home beginning at 6 mo of age, may help prevent growth faltering in early childhood. Preliminary results from Malawi and Ghana suggest that daily consumption of 20-50 g of LNS for 6-12 months increases linear growth and markedly reduces the incidence of severe stunting before the age of 18 months.
The iLiNS-DOSE trial aims to identify the lowest daily dose of LNS that promotes growth in infants when given between the ages of 6 and 18 months (see full trial protocol at ClinicalTrials.gov, NCT00945698). Specifically, we will assess the growth-promoting effects of LNS given daily to infants at a dose of 10 g, 20 g or 40 g, from 6 to 18 months of age; a comparison group will not receive any study supplement until after 18 months (when they will receive fortified maize-soy porridge). The daily doses of 10 g, 20 g or 40 g of LNS will provide 56 kcal/d, 118 kcal/d and 243 kcal/d, respectively. Mothers will be encouraged to breastfeed their infants on demand during the 12-month intervention. It is possible that children may reduce their intake of breast milk when they are provided with energy-dense LNS-containing complementary foods. Because a reduction in breast milk intake could have a negative impact on infant health, we are assessing breast milk intake in infants participating in the larger intervention trial, at 9-12 months of age.
Specific objective
To estimate breast milk intake in a sub-sample of Malawian infants participating in the LNS intervention trial at 9-12 months of age using the dose-to-mother deuterium oxide dilution technique.
Hypothesis
Mean breast milk intake (g/d) will not differ by group in the sub-sample of infants participating in the larger LNS trial at 9-12 months of age.
Study procedures and research methods
Study procedures: Initially, mothers are weighed to the nearest 0.1 kg using an electronic scale, and measured to the nearest 0.1 cm using a stadiometer. Infants are weighed to the nearest 0.01 kg using an electronic scale; and measured to the nearest 0.1 cm using a length board. After completing the anthropometric measurements, saliva samples are obtained from mothers and infants. Saliva samples are collected from mothers by carefully placing a small piece of cotton wool (cotton ball) in the mother’s mouth and asking her to keep it in her mouth for about 1-2 minutes until it is soaked with saliva. When the cotton wool is fully soaked, the mother is asked to position the cotton wool in the front of her mouth and transfer it directly to the empty barrel of a 20 mL disposable syringe (to prevent contamination of the cotton). The saliva is squeezed out of the soaked cotton wool into a small screw-cap vial. The procedure is repeated using a new piece of cotton wool, if necessary, until 2-4 mL (~1/2 to 1 teaspoon) of saliva is collected. Saliva samples are collected from infants by carefully placing a cotton wool swab into the infant’s mouth for 1-2 minutes until the cotton wool is soaked with saliva. The swab is removed from the infant’s mouth and the cotton is separated from the swab and placed into the empty barrel of a 20 mL disposable syringe. The saliva is squeezed out of the soaked cotton wool into a small screw-cap vial. The procedure is repeated until ~ 2 mL (1/2 teaspoon) of saliva is collected from the baby. The vials are tightly capped and stored at -20oC until analyzed for deuterium enrichment.
After collection of the baseline saliva samples, mothers are asked to drink 30 g (~ 1 ounce) of deuterium oxide from a small polypropylene bottle through a straw. The empty bottle is filled with ordinary drinking water (50 mL) and the mother is asked to drink the water to ensure that all of the deuterium oxide is consumed. Saliva samples are collected from mothers and infants again at 1, 2, 3, 4 and 13, and 14 days after dosing, using the same procedures described above.
Because intake of other foods and illness could potentially affect breast milk intake, we are also assessing infant dietary intake by conducting two repeat 24-hr recalls with the infant’s primary caretaker, and we are assessing infant and maternal morbidity weekly by interview.
Selection of subjects: Infants are randomly selected concurrently from each of the four study groups in the larger LNS intervention trial at the time of enrollment (6 mo of age); however procedures for the sub-study do not begin until infants are 9-12 months of age. Enrollment will be on-going during a one-year period. A total of 400 mother-baby pairs will be selected for the sub-study. Informed consent is obtained from mothers who choose to participate with their infants. The study protocol has been approved by the Institutional Review Boards of the College of Medicine, University of Malawi and the University of California, Davis.
Measurement of deuterium enrichment of saliva samples: The deuterium enrichment of saliva samples is measured using Fournier Transform Infra-red Spectroscopy (FTIR) (Jennings, 1999). Briefly, saliva samples are thawed at room temperature and centrifuged at 1000g for 10 minutes. The FTIR cell is filled with saliva and absorbance is measured between 2300 – 2900 nm. Deuterium enrichment of the samples is calculated using a standard curve that is developed with standards of known deuterium enrichment.
Estimation of average daily breast milk intake: Average daily breast milk intake will be calculated from deuterium enrichment data from mother-infant pairs using a two compartment, steady-state model, as previously described (Coward, 1982).
Dietary intake: Dietary intake of infants is assessed by interviewing the infant’s primary caretaker using the 24- hr recall method.
Morbidity: Maternal and infant morbidity is assessed weekly by asking the mother to recall whether she or her infant experienced selected symptoms of illness during the previous week using a questionnaire.
Sample size: The sample size was based on a minimal detectable difference in breast milk intake that represents less than 10% of total energy needs at 9-11 months of age. A difference of 86 g/d in milk intake represents approximately 55-60 kcal, which is 8-9% of total energy needs of 686 kcal/day at 9-11 months of age (Dewey & Brown, 2003). Assuming average milk intake at 9-11 months of age is 616 g/d ± 172 g/d (WHO, 1998), a sample size of 89 mother-infant pairs per group is needed to detect a difference in milk intake of 86 g/d by group, (a=0.05, ß=0.80, effect size=0.5). The sample size was increased to 100 per group (total of 400) to account for attrition.
Data analysis: Mean breast milk intake will be compared by study group using analysis of covariance.
References:
Coward WA, Cole TJ, Sawyer MG, Prentice AM. Breast milk intake measurement in mixed-fed infants by administration of deuterium oxide to their mothers. Hum Nutr Clin Nutr. 1982; 36:141-8.
Dewey KG, Brown KH. Update on technical issues concerning complementary feeding of young children in developing countries and implications for intervention programs. Food Nutr Bull; 2003; 24(1):5-28.
Jennings G, Bluck L, Wright A, Elia, M. The use of infrared spectrophotometry for measuring body water spaces. Clin Chem 1999:1077-81.
Jones PJ, Leatherdale ST. Stable isotopes in clinical research: safety reaffirmed. Clin Sci. 1991:277-280.
World Health Organization. Complementary feeding of young children in developing countries: a review of current scientific knowledge. WHO, Geneva,1998.

From http://www.ilins.org/lns-research-network/information-sharing

Researchers from the Prince Leopold Institute of Tropical Medicine and Ghent University are collaborating on a series of activities. A first set of research activities is built upon the hypothesis of the fetal origin of disease. The effect of daily maternal supplementation with a fortified lipid-based nutrient supplement (LNS) on birth outcomes and child growth during the first year of life in rural Burkina Faso was evaluated and results published (MISAME trial); there is now a follow-up study underway. A second set of activities includes efficacy and effectiveness studies on the use of enhanced LNS-based complementary foods in Ethiopia and Burkina Faso. In Ethiopia the primary focus is on testing the effect of omega 3 supplements in optimized complementary feeding. This study is registered at ClinicalTrials.gov as NCT01817634. The study in Burkina Faso focuses on the treatment of moderate and severe malnutrition with lipid-based supplements. The LUCOMA study (treatment of moderate malnutrition) is registered at ClinicalTrials.gov as NCT01115647.

Unit of Nutrition and Child Health, Public Health Department, Prince Leopold Institute of Tropical Medicine (ITM), Belgium and Research Group Food Chemistry and Human Nutrition Department of Food Safety and Food Quality Faculty of Bioscience Engineering, Ghent University, Belgium (contributed by Patrick Kolsteren, updated February 2014)

http://clinicaltrials.gov/ct2/show/NCT01562379?term=NCT01562379&rank=1

Johns Hopkins University is conducting, in partnership with WFP and icddr,b and with in-kind support from DSM Ltd, a five arm, randomized controlled trial of complementary food supplementation among children 6-18 months of age (n=5,340) in rural Bangladesh. The complementary food supplements (CFS) being tested are provided daily for a year to infants after completing 6 months of age until 18 months to evaluate impact on growth, stunting, wasting, morbidity, micronutrient status, and cognitive development. Two of the foods have been developed in country by icddr,b with WFP assistance and the third is the WFP’s wheat-soy blend (WSB++ ). The two local CFS have improved energy density, increased intrinsic as well as supplemental micronutrient bioavailability, and contain dairy protein. The food supplements are provided in amounts that fill the estimated gap in the nutritional requirements of children 6-18 months of age. All women in the trial receive nutrition counseling, with 1 arm, receiving no CFS, serving as the control. The fifth arm is a positive control arm being provided Plumpy Doz (gratis from Nutriset). The project is expected to be completed in the summer of 2014. The trial is registered at ClinicalTrials.gov as NCT01562379.

Johns Hopkins University, World Food Programme, and International Centre for Diarrhoeal Disease Research, Bangladesh (contributed by Parul Christian, updated March 2014)

This study is ongoing, but not recruiting participants.
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
United Nations World Food Programme (WFP)
DSM Ltd
Information provided by (Responsible Party):
Parul Christian, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01562379
First received: March 9, 2012
Last updated: August 22, 2014
Last verified: August 2014

Descriptive Information
Brief Title ICMJE Complementary Food Supplements for Reducing Childhood Undernutrition
Official Title ICMJE Evaluation of Complementary Food Supplements For Reducing Childhood Undernutrition: The JiVitA-4 Study
Brief Summary
The purpose of this study is to test the impact on child growth of three specially formulated complementary food supplements vs. Plumpy'Doz, a previously tested, commercially available complementary food, and vs. a control group that receives no food. All groups will receive nutrition education related to infant and young child feeding. This will be a cluster-randomised trial in children 6-18 months old in rural Rangpur and Gaibandha in Bangladesh.

Detailed Description
Childhood stunting and growth faltering is highly prevalent in South Asia. Among other strategies, adequate complementary feeding practices and provision of complementary foods that are appropriate and fill the nutrient gap by providing macro and micronutrients essential for growth are important means to reduce the global burden of undernutrition and related morbidity and mortality.

We propose to evaluate the impact of three complementary food supplement products that are fortified with micronutrients in a rural, remote setting in Bangladesh, where high rates of childhood undernutrition persist on child growth, health, and development. The three foods being tested are an enhanced wheat-soy blend (WSB++) developed by WFP, and locally developed chickpea-based and a rice-based complementary food supplements.

We will assess the impact of feeding these daily against the non-fed controls, hypothesizing that the children fed these foods show increased length for age Z scores (LAZ) and weight for length age Z scores (WLZ) of >0.21 and decreased prevalence of stunting and wasting by >10%. We expect that the impact of the three foods will be equivalent/ non-inferior to that of Plumpy'Doz.

Study Type ICMJE Interventional
Study Phase Phase 2
Phase 3
Study Design ICMJE Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Condition ICMJE
Stunting
Wasting
Intervention ICMJE
Dietary Supplement: Wheat Soy Blend (WSB++)
A wheat formulation containing protein from milk solids and soybeans, essential fats and sugar to provide optimal caloric density, and added vitamins and minerals.
Dietary Supplement: Chickpea based complementary food supplement
A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals.
Dietary Supplement: Rice based complementary food supplement
Locally developed rice based complementary food with and added vitamins and minerals.
Dietary Supplement: Plumpy Doz
Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals.
Study Arm (s)
No Intervention: No food
A control in which mothers will receive nutrition education about continued breastfeeding and adequate complementary feeding throughout the period of 6-18 months of age.
Active Comparator: Plumpy Doz
In this control arm children will receive prepackaged, lipid-based Plumpy'Doz (Nutriset, Mulaunay, France) for daily consumption as a snack.
Intervention: Dietary Supplement: Plumpy Doz
Experimental: Wheat Soy Blend (WSB++)
Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily.
Intervention: Dietary Supplement: Wheat Soy Blend (WSB++)
Experimental: Chickpea based complementary food supplement
Children will receive a Chickpea based complementary food supplement to be consumed daily.
Intervention: Dietary Supplement: Chickpea based complementary food supplement
Experimental: Rice based complementary food supplement
Children will receive a locally developed rice based complementary food supplement.
Intervention: Dietary Supplement: Rice based complementary food supplement
Publications * Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ICMJE Active, not recruiting
Estimated Enrollment ICMJE 5320
Estimated Completion Date November 2014
Primary Completion Date May 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ICMJE
Inclusion Criteria:

Infants 6 months of age
Gender Both
Ages 6 Months to 8 Months
Accepts Healthy Volunteers Yes
Contacts ICMJE Contact information is only displayed when the study is recruiting subjects
Location Countries ICMJE Bangladesh

Administrative Information
NCT Number ICMJE NCT01562379
Other Study ID Numbers ICMJE 00003703, NIFA210-38418-21732
Has Data Monitoring Committee Yes
Responsible Party Parul Christian, Johns Hopkins Bloomberg School of Public Health
Study Sponsor ICMJE Johns Hopkins Bloomberg School of Public Health
Collaborators ICMJE
International Centre for Diarrhoeal Disease Research, Bangladesh
United Nations World Food Programme (WFP)
DSM Ltd
Investigators ICMJE
Principal Investigator: Parul Christian, DrPH Johns Hopkins Bloomberg School of Public Health
Study Director: Keith P West, DrPH Johns Hopkins Bloomberg School of Public Health
Study Director: Rolf Klemm, DrPH Johns Hopkins Bloomberg School of Public Health
Study Director: Alain B Labrique, PhD Johns Hopkins Bloomberg School of Public Health
Study Director: Kerry J Schulze, PhD Johns Hopkins Bloomberg School of Public Health
Study Director: Sucheta Mehra, MS Johns Hopkins Bloomberg School of Public Health
Study Director: Rebecca Merrill, PhD Johns Hopkins Bloomberg School of Public Health
Study Director: Abu Ahmed Shamim, MS JiVitA
Study Director: Hasmot Ali, MPH JiVitA
Study Director: Tahmeed Ahmed, PhD International Centre for Diarrhoeal Disease Research, Bangladesh
Study Director: Saskia de Pee, PhD WFP
Study Director: Martin Bloem, PhD WFP
Study Director: Monira Parveen, PhD WFP
Study Director: Britta Schumacher, PhD WFP
Information Provided By Johns Hopkins Bloomberg School of Public Health
Verification Date August 2014

From: http://www.ilins.org/lns-research-network/information-sharing

Timing of maternal nutrition intervention – Democratic Republic of the Congo and other sites
The University of Colorado School of Medicine, supported by the Bill & Melinda Gates Foundation, the Global Network for Women’s and Children’s Health Research, and RTI International will implement an individually randomized controlled trial of the impact of the timing of a maternal nutrition intervention on infant outcomes (trial name “Women First: Preconception Maternal Nutrition”). Study sites are in the Western Highlands of Guatemala; Northern Karnataka, India; Thatta District, Sindh Province, Pakistan; and The Democratic Republic of the Congo. Women will receive either no LNS or daily LNS (modeled on the iLiNS formulation) with 118 kcal/d, commencing either = 3 months preconception or at 12 weeks gestation. Women in either LNS study arm with low BMI (<19) or low weight gain (below U.S. Institute of Medicine recommendations) will in addition receive an energy and protein balanced food supplement of 300 kcal/d, without significant additional micronutrients. The primary outcome is birth length; secondary outcomes include: fetal length (longitudinal); incidence of low birth weight, infant anthropometry up to 6 mo, and infant morbidity. Enrollment commenced January 2014 in Guatemala, India, and Pakistan. Duration of study: 2012 – 2017. Registered at ClinicalTrials.gov as NCT01883193.

The University of Colorado School of Medicine, Bill & Melinda Gates Foundation, Global Network for Women’s and Children’s Health Research, and RTI International (contributed by Michael Hambidge, updated February 2014).

From: http://www.ilins.org/lns-research-network/information-sharing

Full study name: A Cluster Randomized Controlled Trial of the Benefits of Sanitation, Water Quality, Handwashing, and Nutrition Interventions on Child Health and Development. The WASH Benefits Study will provide rigorous evidence on the health and developmental benefits of water quality, sanitation, handwashing, and nutritional interventions during the first years of life. The nutritional intervention will include infant and young child feeding behavior change messaging plus the delivery of lipid-based nutrient supplements for children 6-24 months of age. The study includes two, cluster-randomized controlled trials to measure the impact of each intervention among infants in rural Bangladesh and Kenya. The studies are large in scope (~720 clusters with ~5000 newborns in Bangladesh and ~1125 clusters with 10,000 newborns in Kenya) and will measure primary outcomes 12 and 24 months after intervention delivery. Children born into the cohorts will be assessed for length-for-age, diarrhea prevalence, child development, stunting, and, in a subsample, environmental enteropathy biomarkers. The two trials began enrollment in mid to late 2012. A paper describing study design is available here: abstract and free full text.

Project duration 2012-2015. For more information, please see the project website: www.washbenefits.net. Registered at ClinicalTrials.gov as NCT01590095 (Bangladesh) and NCT01704105 (Kenya).

UC Berkeley, Stanford University, Emory University, Innovations for Poverty Action, Kenya Medical Research Institute, ICDDR,B, Johns Hopkins University, and UC Davis (Contributed by Christine Stewart, October 2012)

From: http://www.ilins.org/lns-research-network/information-sharing

The Medical Research Council (MRC) UK’s International Nutrition Group has recently initiated two studies at their field station in Keneba, The Gambia both aimed at generating a detailed understanding of the health and immunological responses to supplementary multiple micronutrients, given in the form of LNS.

The first project is a randomized trial to investigate the effects of physician-prescribed LNS on the health of children presenting to a primary health care centre in The Gambia. This study will have a specific target population, i.e. vulnerable children that self-select by presentation at the clinic, and main endpoints are return presentations at clinic and growth. A sub-study will specifically focus on children with lower-respiratory tract infections (LRTI). Time frame 2009-2011. This study is registered at www.controlled-trials.com as ISRCTN73571031.

Intervention:
Randomised double-blind placebo-controlled trial of 25 g/d LNS (containing macronutrients and 23 micronutrients) under Good Clinical Practice (GCP) standards. Supplement will be administered by the carer. Compliance will be assessed by unannounced observations and questionnaires. Subjects will be randomised into three groups:
1. 12 week LNS supplementation
2. 6 week LNS supplementation followed by 6 week placebo
3. 12 week placebo

Each child will be followed up for 1 year.

The second study will employ a randomized design to investigate the effects of combined pre-natal and infancy supplementation on infant immune development. This trial will seek to establish (a) which combination of supplements would be most effective and (b) the most critical periods of intervention in pregnancy and infancy. Project duration 2009-2014. A methods paper is available for the second study – abstract and free full text. Registered at www.controlled-trials.com as ISRCTN49285450.

The Medical Research Council (MRC) The Gambia (originally contributed by Sophie Moore, updated by Mary Arimond October 2012 based on ISRCT listings and PubMed search)

From: http://www.ilins.org/lns-research-network/information-sharing

This study will evaluate the effectiveness of intensive nutrition counseling with or without small quantity lipid-based nutrient supplements (LNS) or counseling on early childhood stimulation and development as a preventive tool for child stunting in Madagascar. This study will serve as an impact evaluation of a series of alternative intervention packages conducted within the context of the Government of Madagascar National Nutrition Program (Programme National de la Nutrition Communautaire or PNNC). There are five arms: (1) Control: Program as currently designed, a community-based nutrition program with growth monitoring and education; (2) Intensive maternal, infant, and young child nutrition (MIYCN) counseling including investments in human resources to support personalized counseling with mothers; (3) Intensive MIYCN counseling + 20 g lipid based supplementation (LNS) to children 6-18 months (under the brand name “Kalina Be”); (4) Intensive MIYCN counseling + 20 g LNS to children 6-18 months + 40 g LNS pregnant and lactating women (under the brand name “Kalina Reny”); (5) Intensive MIYCN counseling + early childhood stimulation and development for children 6-18 months. The primary outcomes of the evaluation are child growth, child development, and risk of anemia. Cost effectiveness of each alternative intervention package will also be evaluated. Duration of study 2014 – 2017.

University of California (UC), Davis, The World Bank, UC Berkeley, IFPRI, Programme National de la Nutrition Communautaire (PNNC) (contributed by Christine Stewart, March 2014)

From: http://www.ilins.org/lns-research-network/information-sharing

The Governments of Malawi and Mozambique are undertaking large-scale community-based stunting prevention programs, supported by the World Food Programme and with funding from the Children’s Investment Fund Foundation. Program elements include nutrition and breastfeeding education for pregnant and lactating women (PLW) and caregivers of children less than two years of age; behavior-change communication targeted at health workers, the community, and caregivers around diet, nutrition and feeding practices; distribution of small-quantity LNS to all children 6-23 months of age; and distribution of a fortified blended food for the treatment of moderate acute malnutrition in PLW. With a main objective of preventing stunting, secondary objectives include: 1) pilot test an innovative approach to program registration and monitoring using ICT solutions to improve WFP operational capacity; 2) explore mechanisms for improving demand and use of the program; 3) assess types and measurement techniques of appropriate process indicators of program performance; and 4) evaluate methods to optimize supply chain management. WFP will continuously monitor the program and make changes to the design as needed. Strong monitoring and complementary operational research will allow WFP to fully address secondary objectives. An external evaluator will measure nutrition indicators to assess program impact. Project duration 2013-2017. Download a detailed abstract here.

Malawi Government, Mozambique Ministry of Health, World Food Programme (Malawi and Mozambique), and CIFF, (Contributed by Nancy Aburto, updated April 2014)

From: http://www.ilins.org/lns-research-network/information-sharing

The Millennium Villages Project (MVP) implements integrated interventions in agriculture, education, health, infrastructure, gender equality, and business development, including interventions to support optimal breastfeeding and complementary feeding. MVP sites have shown improvements in household food security and diet diversity and the prevalence of stunting has declined. However, stunting levels are still high, particularly in some sites. In one high-stunting site (Ruhiira, in Uganda) MVP will undertake operational research on several approaches to preventing stunting by increasing the nutritional quality of complementary foods. The objectives of the research are to assess which approach: 1) is most acceptable among the rural population participating in the MVP; 2) results in the greatest prevention of stunting, and 3) is most suitable for scaling-up as part of the integrated development approach piloted by the MVP. This study is still in the preparation phase. Approaches under consideration include increasing dietary diversity through provision of locally available nutrient-dense foods, provision of a fortified complementary food (CSB++), and provision of LNS (Nutributter), all from 6-24 mo of age. The main donor for this project is Table for Two. Project duration 2013-2015.

Millennium Villages Project, World Food Programme (Contributed by Roseline Remans, November 2012)

from: http://www.ilins.org/lns-research-network/information-sharing

The SHINE Project hypothesizes that environmental enteropathy is a major cause of child stunting and anemia, and that EE can be reduced through a package of interventions that improve household sanitation and hygiene. SHINE will measure the independent and combined effects of improved infant diets and improved sanitation/hygiene. In the infant nutrition arms of the study, SHINE will seek to improve infant diets through promoting optimal use of local foods and through use of LNS (Nutributter®) to fill remaining nutrient gaps (iron and zinc). Following a series of preliminary and formative studies and pilot testing of interventions, SHINE began enrolling participants in October of 2012. Project duration 2012-2015. Registered at ClinicalTrials.gov as NCT01824940.

Zimbabwe Ministry of Health and Child Welfare, Zvitambo, Johns Hopkins Bloomberg School of Public Health, Cornell University, University of London, London School of Hygiene and Tropical Medicine (advisory) (Contributed by Rebecca Stoltzfus, October 2012)

http://clinicaltrials.gov/ct2/show/NCT01072279?term=%23+NCT01072279&rank=1

From: http://www.ilins.org/lns-research-network/information-sharing

Comparing LNS, CSB, MNP - Guatemala

The International Food Policy Research Institute (IFPRI), in partnership with the USAID-funded Food and Nutrition Technical Assistance Project (FANTA), is comparing the impact of LNS, corn-soy blend (CSB) or micronutrient powder (MNP) on child anthropometry in a Title II Maternal and Child Health and Nutrition program implemented by Mercy Corps in Guatemala. In addition to individual rations (LNS, CSB or MNP), the intervention package includes family food rations, which are conditional on mothers attending regular behavior change communication sessions and preventive health care services for pregnant and lactating women and for infants and young children up to 2 years of age. The research is part of a large-scale evaluation of the "Preventing Malnutrition in Children Under-2 Approach" (PM2A) conducted in Guatemala and Burundi. Project duration: 2010-2014. Registered at ClinicalTrials.gov as NCT01072279.

International Food Policy Research Institute , Food and Nutrition Technical Assistance III Project (FANTA), and Mercy Corps (contributed by Deanna Olney and Jef Leroy, updated February 2014)

his study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by International Food Policy Research Institute
Sponsor:
International Food Policy Research Institute
Collaborators:
Food and Nutrition Technical Assistance Project 2 of the Academy of Educational Development
United States Agency for International Development (USAID)
Catholic Relieve Services-Burundi
Mercy Corps-Guatemala
Information provided by (Responsible Party):
International Food Policy Research Institute
ClinicalTrials.gov Identifier:
NCT01072279
First received: February 17, 2010
Last updated: January 1, 2013
Last verified: January 2013
History of Changes

Descriptive Information
Brief Title ICMJE Preventing Malnutrition in Children Under Two Years of Age Approach
Official Title ICMJE Strengthening and Evaluating the "Preventing Malnutrition in Children Under Two Years of Age Approach" (PM2A) in Guatemala and Burundi
Brief Summary
A study conducted by IFPRI in Haiti provided the first programmatic evidence, using a cluster randomized evaluation design, that preventing child undernutrition in children under two years of age (PM2A) through an integrated program providing food rations, BCC and preventive health and nutrition services is both feasible and highly effective. The study's principal aim was to compare a newly designed preventive approach with the traditional (recuperative) food assisted MCHN program approach, and therefore included only two comparison groups: one group of communities that was randomly assigned to the preventive approach and another group assigned to the recuperative approach. For logistical and financial reasons, the study did not include a randomized control group receiving no intervention.

The Haiti study design was well-suited to achieve its main goal - i.e. to test whether the preventive approach was more effective than the recuperative approach at preventing child undernutrition - but it left a number of questions unanswered.

The present study will address several of these questions, which will allow to further refine the PM2A approach, facilitate its replication in different contexts, and maximize its impact and cost-effectiveness in future programming. The study will be conducted in Guatemala and Burundi. The key research objectives are:

Impact and cost effectiveness: Assess the impact and cost effectiveness of PM2A on child nutritional status.
Optimal composition and size of food rations in PM2A: Assess the differential and absolute impact of varying the size and types of foods incorporated in the food ration of the PM2A. More specifically, assess the differential effect of different sizes of family food rations, and assess the impact of substituting the individual food ration with new micronutrient-rich products such as lipid-based nutrient supplements (LNS) or micronutrient Sprinkles.
Optimal timing and duration of PM2A: Assess the differential and absolute impact of varying the timing and duration of exposure to PM2A on child nutritional status.
Detailed Description Not Provided
Study Type ICMJE Interventional
Study Phase Not Provided
Study Design ICMJE Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Condition ICMJE Malnutrition
Intervention ICMJE
Other: Tubaramure (Burundi)
Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices
Other: Procomida (Guatemala)
Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices
Study Arm (s)
Experimental: Burundi: T24
Intervention: Other: Tubaramure (Burundi)
Experimental: Burundi: TNFP
Intervention: Other: Tubaramure (Burundi)
Experimental: Burundi: T18
Intervention: Other: Tubaramure (Burundi)
No Intervention: Burundi: Control
Experimental: Guatemala: PROCOMIDA
Intervention: Other: Procomida (Guatemala)
Experimental: Guatemala: no family ration
Intervention: Other: Procomida (Guatemala)
Experimental: Guatemala: LNS
Intervention: Other: Procomida (Guatemala)
Experimental: Guatemala: Sprinkles
Intervention: Other: Procomida (Guatemala)
Experimental: Guatemala: reduced family ration
Intervention: Other: Procomida (Guatemala)
No Intervention: Guatemala: control
Publications *
Loechl CU, Menon P, Arimond M, Ruel MT, Pelto G, Habicht JP, Michaud L. Using programme theory to assess the feasibility of delivering micronutrient Sprinkles through a food-assisted maternal and child health and nutrition programme in rural Haiti. Matern Child Nutr. 2009 Jan;5(1):33-48.
Menon P, Mbuya M, Habicht JP, Pelto G, Loechl CU, Ruel MT. Assessing supervisory and motivational factors in the context of a program evaluation in rural Haiti. J Nutr. 2008 Mar;138(3):634-7.
Ruel MT, Menon P, Habicht JP, Loechl C, Bergeron G, Pelto G, Arimond M, Maluccio J, Michaud L, Hankebo B. Age-based preventive targeting of food assistance and behaviour change and communication for reduction of childhood undernutrition in Haiti: a cluster randomised trial. Lancet. 2008 Feb 16;371(9612):588-95.
Menon P, Ruel MT, Loechl CU, Arimond M, Habicht JP, Pelto G, Michaud L. Micronutrient Sprinkles reduce anemia among 9- to 24-mo-old children when delivered through an integrated health and nutrition program in rural Haiti. J Nutr. 2007 Apr;137(4):1023-30.
Menon P, Ruel MT, Loechl C, Pelto G. From research to program design: use of formative research in Haiti to develop a behavior change communication program to prevent malnutrition. Food Nutr Bull. 2005 Jun;26(2):241-2. No abstract available.
Ruel MT, Menon P, Loechl C, Pelto G. Donated fortified cereal blends improve the nutrient density of traditional complementary foods in Haiti, but iron and zinc gaps remain for infants. Food Nutr Bull. 2004 Dec;25(4):361-76.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ICMJE Recruiting
Estimated Enrollment ICMJE 9184
Estimated Completion Date October 2013
Estimated Primary Completion Date October 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ICMJE
Inclusion Criteria:

Guatemala: pregnant mothers and subsequently their born children up to the age of 24 months;
Burundi: cross-sectional study: children 0 to 42 of age.
Exclusion Criteria:

none
Gender Both
Ages up to 42 Months
Accepts Healthy Volunteers Yes
Contacts ICMJE
Contact: Jef L Leroy, PhD j.leroy@cgiar.org
Contact: Deanna Olney, PhD d.olney@cgiar.org
Location Countries ICMJE Burundi, Guatemala

Administrative Information
NCT Number ICMJE NCT01072279
Other Study ID Numbers ICMJE 4001-IFPRI-00
Has Data Monitoring Committee No
Responsible Party International Food Policy Research Institute
Study Sponsor ICMJE International Food Policy Research Institute
Collaborators ICMJE
Food and Nutrition Technical Assistance Project 2 of the Academy of Educational Development
United States Agency for International Development (USAID)
Catholic Relieve Services-Burundi
Mercy Corps-Guatemala
Investigators ICMJE
Principal Investigator: Marie Ruel, PhD IFPRI
Information Provided By International Food Policy Research Institute
Verification Date January 2013

ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

From: http://www.ilins.org/lns-research-network/information-sharing

Full study name: Evaluation of the Nutritional Status of Pregnant and Lactating Women and Their Children Enrolled in the LAMB Project in Bangladesh. Since 2009, the USAID-funded Food and Nutrition Technical Assistance Project (FANTA) has been involved in the development and implementation of research evaluating the potential of LNS and micronutrient powder (MNP) for prevention of malnutrition. In collaboration with the University of California, Davis, the International Centre for Diarrheal Disease Research, Bangladesh and World Mission Prayer League (LAMB Hospital), the effectiveness of LNS and MNP for prevention of chronic malnutrition is being explored in Bangladesh through a cluster-randomized controlled trial of approximately 4011 women and children. The study enrolled women in early pregnancy into one of three intervention arms: 1) LNS during pregnancy, the first 6 months postpartum and for the infant from 6-24 months; 2) Iron and folic acid (IFA) tablets during pregnancy, the first 3 months postpartum and LNS from 6-24 months; 3) IFA tablets during pregnancy, the first 3 months postpartum and MNP from 6-24 months. These intervention arms are compared to a 4th study arm that received the standard of care in this program setting: IFA tablets during pregnancy through 3 months postpartum. Outcomes include nutritional status of pregnant/postpartum women (including micronutrient status), birth outcomes, and linear growth, motor and cognitive development and micronutrient status of infants 6-24 months of age. The cost-effectiveness of the LNS product compared to other interventions, and willingness-to-pay for LNS and MNP products in this population are also being explored. Project duration 2009-2015. Registered at ClinicalTrials.gov as NCT01715038.

Food and Nutrition Technical Assistance III Project (FANTA), UC Davis, ICDDR,B, and LAMB Hospital (updated by Malay Mridha and Zeina Maalouf-Manasseh, February 2014)

from: http://www.ilins.org/lns-research-network/information-sharing

Project Concern International (PCI) is implementing an International Food Relief Partnership (IFRP) program through USAID funding in Jinotega, Nicaragua. USAID IFRP grants provide funds to transport and distribute the commodity Nutributter, while PCI builds the capacity of beneficiaries to increase their income, cultivate nutritious foods, and be better linked to quality health services. PCI collaborates with the Ministry of Health (MOH) of Nicaragua to supplement children 6-24 months with Nutributter during monthly MOH-supported Growth Monitoring and Promotion (GMP) and counseling program. This is one of the first LNS distributions through MOH-supported nutrition activities in Latin America. In collaboration with Edesia, Inc., the maker of Nutributter, PCI undertook a qualitative research study to assess stakeholders' experience in linking a LNS supplement with a health care program, and the feasibility of using LNS supplementation as a tool for promoting attendance to MOH health and nutrition programs. Project duration: 2011-2013.

Project Concern International (PCI), Centro de Estudios y Promoción Social (CEPS), Washington University, Edesia, Inc. (contributed by Gwenelyn O'Donnell-Blake, March 2014)

The general objectives were to determine the level of satisfaction and adherence to Nutributter use in children aged 6-23 months, and to identify the BCC strategy to put in place for future program implementation. This activity took place in four camps in Eastern Chad hosting Sudanese populations. The standard protocol outlined in UNHCR Operational Guidance on the Use of Special Nutritional Products to Reduce Micronutrient Deficiencies and Malnutrition in Refugee Populations was adapted and followed:

http://www.unhcr.org/pages/52176e236.html